The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
Public safety on the roadways is the chief objective of the Federal Motor Carrier Safety Regulations (FMCSRs). Some safety and operations teams will from time to time encounter unique circumstances where strict compliance can...more
On August 23, 2023, the U.S. Securities and Exchange Commission (“SEC”), by a party-line vote of 3-2, adopted new rules applicable to investment advisers to private funds (“Private Fund Advisers”) that address transparency,...more
On August 23, 2023, by a vote of 3-2, the Securities and Exchange Commission (the “SEC”) adopted new final rules and amendments to existing rules under the Investment Advisers Act of 1940, as amended (the “Advisers Act”) with...more
The Build America, Buy America Act generally requires that non-federal government infrastructure projects that benefit from federal government funding impose requirements for the use of domestic iron and steel and...more
On January 30, 2023, the Biden Administration announced plans to end the Public Health Emergency (PHE) on May 11, 2023. The PHE was enacted on January 27, 2020, to provide flexibility to healthcare providers and payors...more
President Joe Biden signed into law the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 (2023 NDAA or Defense Bill) on Dec. 23, 2022. The Defense Bill, which passed the U.S. House of Representatives on...more
The Supreme Court of Texas recently addressed notice requirements in a construction contract. In James Construction Group, LLC v. Westlake Chemical Corporation, the court held that even though the substantial compliance...more
Passing the historic $1 trillion Infrastructure Investment and Jobs Act (IIJA) in November 2021, which allocates more than $550 billion in new infrastructure spending, was an early priority of the Biden administration. The...more
King & Spalding’s April Client Alert provided an overview of and practical advice related to issues that an employer should consider before conducting an internal investigation in the United Kingdom: privilege, privacy,...more
For health care providers, particularly long term care providers, COVID-19 has brought unprecedented challenges. In response to those challenges, both the federal and state governments have responded over the course of the...more
Telehealth has become an integral part of care delivery, particularly in light of the waivers instituted during COVID-19. However, these flexibilities remain in flux and at the same time, government scrutiny and enforcement...more
The onset of the novel Coronavirus pandemic (“COVID-19”) led to an abrupt shutdown of businesses worldwide and across numerous industries. The shutdown’s impact on the commercial real estate market generally, and on REITs...more
As states allow businesses to reopen and employers begin returning to the workplace, questions arise regarding the potential liability of employers if employees and consultants contract COVID-19 in the workplace—which might...more
HCCA has assembled a half-day virtual conference to help compliance professionals stay on top of the fast-moving changes caused by the COVID-19 pandemic. By participating in this event, you will hear directly from the...more
In an effort to curb the potential risk associated with reliance upon the Russian Federation for energy, the Department of Defense issued a class deviation that prohibits contractors from using any Russian-sourced energy to...more
As healthcare moves increasingly from fee-for-service model to one focused on outcomes and value-based payments, the traditional fraud and abuse laws, such as the Anti-Kickback Statute and the Stark Law, pose obstacles to...more
In our prior bulletin, we discussed the likely lack of civil immunity from Justice Center enforcement actions conferred in other contexts by Executive Order 202.10. However, other Executive Orders provided some relief in the...more
The impact of Coronavirus (COVID-19) on hospitals and health systems is unprecedented. On the frontlines combatting the pandemic, the industry is also facing a financial crisis and a rapidly evolving regulatory and legal...more
Examine the Evolving Challenges That Lie Ahead for Healthcare Stakeholders and State Regulators—and What You Can Do Now to Prepare and Protect Your Organization—at a New Manatt Webinar. Effective health insurance...more
Topics to be presented: HIPAA, Telehealth, and Other Compliance Flexibilities Presented by Patricia A. Markus Stark Waivers and Medicare Advance Payments Presented by Lester J. Perling Compliance and Enforcement ...more
In this week’s episode, Mary Beth Johnston, Carolyn Merritt and Leah Richardson discuss the ways in which the Centers for Medicare and Medicaid Services’ (CMS) response to the ongoing COVID-19 outbreak is easing certain...more
Last week, the Alaska Department of Environmental Conservation (“ADEC”) issued two No Action Assurance Memorandums, one from the Division of Water (“Water Memo”) and one from the Division of Air Quality (“Air Memo”), to...more
The Environmental Protection Agency (EPA) has issued a memorandum describing how and when the Agency will implement temporary enforcement discretion for certain federal environmental noncompliance during the COVID-19...more
On March 30, 2020, the Secretary of the United States Department of Health and Human Services (“HHS”) exercised his authority to waive certain Medicare requirements during an emergency and issued blanket waivers of sanctions...more
In response to the global Coronavirus (COVID-19) pandemic, US state and federal government agencies are promoting expanded use of telehealth. Prior to and following president Trump’s declaration of a national emergency...more